WO2021261500A1 - 外針組立体 - Google Patents

外針組立体 Download PDF

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Publication number
WO2021261500A1
WO2021261500A1 PCT/JP2021/023686 JP2021023686W WO2021261500A1 WO 2021261500 A1 WO2021261500 A1 WO 2021261500A1 JP 2021023686 W JP2021023686 W JP 2021023686W WO 2021261500 A1 WO2021261500 A1 WO 2021261500A1
Authority
WO
WIPO (PCT)
Prior art keywords
outer needle
tube
flow path
base end
end side
Prior art date
Application number
PCT/JP2021/023686
Other languages
English (en)
French (fr)
Japanese (ja)
Inventor
衝 貞廣
裕之 中神
辰也 工藤
直也 片岡
Original Assignee
ニプロ株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by ニプロ株式会社 filed Critical ニプロ株式会社
Priority to CN202180044117.8A priority Critical patent/CN115835899A/zh
Priority to US18/011,975 priority patent/US20230256206A1/en
Priority to EP21829750.5A priority patent/EP4169551A1/en
Priority to JP2022532505A priority patent/JPWO2021261500A1/ja
Priority to AU2021297440A priority patent/AU2021297440A1/en
Priority to CA3187022A priority patent/CA3187022A1/en
Publication of WO2021261500A1 publication Critical patent/WO2021261500A1/ja

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0606—"Over-the-needle" catheter assemblies, e.g. I.V. catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
    • A61M2039/062—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof used with a catheter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
    • A61M2039/0633—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof the seal being a passive seal made of a resilient material with or without an opening
    • A61M2039/0653—Perforated disc

Definitions

  • the present invention relates to an outer needle assembly in which a flow path forming member is connected to the base end side of the outer needle, in particular, a ventilation path capable of discharging air from the lumen of the flow path forming member to the outside, and a flow path forming member. It relates to an outer needle assembly provided with a valve body that communicates / blocks the lumen of the body.
  • an external needle assembly used for dialysis, infusion, etc. has been known.
  • the outer needle assembly is connected to the hollow outer needle in a communicating state with the base end side of the outer needle, for example, like the indwelling needle disclosed in Japanese Patent Application Laid-Open No. 2015-080707 (Patent Document 1). It has a flow path forming member such as a needle base.
  • the outer needle assembly is placed in the blood vessel or the like by removing the inner needle after the outer needle is punctured into the blood vessel or the like of the patient together with the inner needle. Then, dialysis or infusion is performed by connecting an external flow path such as a dialysis circuit or an infusion line to the outer needle assembly placed in a blood vessel or the like.
  • a rubber stopper portion as a valve body is housed in the outer needle base, and the slit valve provided in the rubber stopper portion opens and closes to communicate and block the lumen of the outer needle base.
  • the slit valve of the rubber stopper is opened by connecting the external flow path to the external needle group, so that the external flow path is communicated with the blood vessel through the lumen of the indwelling needle.
  • Patent Document 1 when blood flows into the lumen of the indwelling needle (outer needle assembly), air is discharged to the outside through a gap as a ventilation path formed between the outer needle base and the rubber stopper. It is supposed to be done.
  • the solution to the present invention is to provide an outer needle assembly having a novel structure capable of preventing residual air.
  • the present inventor first tried to change the shape, size, number, arrangement, etc. of the air passage in order to prevent air from remaining in the lumen of the outer needle assembly, but it is not possible to obtain a sufficient effect. could not.
  • the present inventor observed in detail the flow mode of the liquid (corresponding to blood) in the outer needle assembly by an experiment.
  • the liquid flowing from the needle tip of the outer needle reaches the tip in the outer needle assembly. It was confirmed that the position was divided into the side and the proximal side, the discharge of air to the proximal side was obstructed by the liquid, and the air remained between the liquid on the distal end side and the liquid on the proximal end side. ..
  • the present inventor examines the reason why the liquid introduced into the cavity of the outer needle assembly separates into the distal end side and the proximal end side with respect to the residual air, and the air remains in the middle of the liquid.
  • the present inventor when such a stepped diameter-expanded portion is provided in the inner cavity of the outer needle assembly, the cross-sectional area of the inner cavity of the outer needle assembly through which the liquid flows suddenly expands on the way. Therefore, it was estimated that a region not filled with liquid would occur in the enlarged diameter portion.
  • the liquid reaches the base end of the outer needle assembly while the air in the region not filled with the liquid remains, and the air passage is blocked by the liquid, so that the discharge of air through the air passage is hindered and the air is discharged.
  • Remained in the middle part of the outer needle assembly and it was considered that the liquid was present on both sides of the residual air.
  • the liquid flows through the stepped diameter-expanded portion in the inner cavity of the outer needle assembly, turbulence is likely to occur due to a sudden change in the cross-sectional area of the flow path, thereby causing turbulence. It was presumed that the inadequate discharge of air due to the entrainment of air in the liquid was also one of the causes of the residual air. Then, the present inventor has come to complete the present invention based on such findings.
  • the first aspect comprises a hollow outer needle through which an inner needle is inserted and a flow path forming member connected to the outer needle, and has a valve body inside the flow path forming member.
  • the first internal space on the tip side of the valve body is an outer needle assembly that is longer than the second internal space on the base end side of the valve body, and the air in the first internal space is released to the outside.
  • the ventilation path is communicated with the first internal space in the vicinity of the valve body, and the first internal space is based on the puncture portion formed in the puncture portion of the external needle into the blood vessel and the puncture portion.
  • the cross-sectional area of the internal space in the small diameter portion is the same as or smaller than the cross-sectional area of the internal space at the base end of the tapered portion, the cross-sectional area of the internal space is the same as or smaller than that of the tapered portion.
  • the configuration of this embodiment capable of preventing the residual air is the member holding the valve body and the outside. It is suitably applied to an outer needle assembly in which a ventilation path and an outer needle are arranged at a large distance from each other, such as by having a tubular member between members for holding the needle. Further, the configuration of this embodiment is particularly preferably applied to an outer needle assembly in which the length of the small diameter portion is longer than the distance from the tip of the tapered portion to the tip of the small diameter portion. Further, a large diameter portion having a larger inner diameter than the small diameter portion is formed on the proximal end side of the small diameter portion, and the large diameter portion may be adjacent to the valve body.
  • the second aspect comprises a hollow outer needle through which the inner needle is inserted and a flow path forming member connected to the outer needle, and has a valve body inside the flow path forming member, and the flow path is provided.
  • An outer needle assembly in which the forming member is provided with a ventilation path for communicating the internal space on the tip side of the valve body to the outside, and a tapered shape in which the base end portion of the outer needle expands in diameter toward the base end.
  • the inner diameter of the flow path forming member is equal to or less than the inner diameter of the outer needle.
  • an enlarged diameter portion having a large diameter on the proximal end side is not formed at the connection portion between the outer needle and the flow path forming member. Therefore, in the connection portion between the outer needle and the flow path forming member in the lumen of the outer needle assembly, it is difficult to form a region not filled by the liquid introduced from the outer needle into the flow path forming member, and the residual air is suppressed. Ru.
  • the base end portion of the outer needle has a tapered shape that expands in diameter toward the base end, the flow velocity of the liquid flowing through the outer needle decreases toward the base end. As a result, the generation of turbulence due to the flow of the liquid is further suppressed at the base end of the outer needle, and the entrainment of air in the liquid is prevented.
  • the third aspect is that in the outer needle assembly described in the second aspect, the inner diameter dimension of the flow path forming member and the inner diameter dimension of the outer needle are set at the connection portion between the outer needle and the flow path forming member. It is the same.
  • the formation of a step is prevented at the connection portion between the outer needle and the flow path forming member, so that turbulent flow occurs in the liquid flowing through the lumen of the outer needle assembly. Generation is further reduced and air entrainment is suppressed.
  • a fourth aspect is the outer needle assembly according to any one of the first to third aspects, wherein the flow path forming member includes a flexible tube, and the tube is attached to the outer needle. It is connected.
  • the tube in the outer needle assembly indwelled by being punctured by a blood vessel or the like, for example, the tube is bent as necessary to make the outer needle assembly into a dialysis circuit or the like. It can be easily connected to an external flow path such as an infusion line.
  • a fifth aspect is that in the outer needle assembly according to the fourth aspect, a large-diameter tubular portion having an increased inner diameter is provided at the tip end portion of the tube, and the base end portion of the outer needle is formed. It is fixed to the large-diameter cylinder portion in an inserted state.
  • the inner diameter of the tube at the connection portion between the outer needle and the tube is determined by inserting and fixing the base end portion of the outer needle into the large diameter cylinder portion of the tube. , It becomes easy to make it smaller than the inner diameter of the outer needle.
  • a sixth aspect is that in the outer needle assembly according to the fifth aspect, the inner diameter and outer diameter dimensions of the tube are larger than those of the large diameter cylinder portion on the proximal end side of the large diameter cylinder portion. It is provided with a small diameter cylinder.
  • the flow path forming member is at the base end rather than the connecting portion with the outer needle while preventing the inner diameter from rapidly expanding at the connecting portion between the outer needle and the flow path forming member. It is possible to prevent the wall from becoming thicker than necessary on the side.
  • a seventh aspect is the outer needle assembly according to any one of the first to sixth aspects, wherein the flow path forming member includes a flexible tube, and the tip of the outer needle is provided.
  • the inner peripheral surface extending from the tube to the base end is not provided with a stepped diameter-expanded portion.
  • the outer needle assembly having a structure according to this aspect, it is avoided that the inner diameter dimension suddenly increases from the tip of the outer needle to the base end of the tube. Therefore, the sudden volume change in the internal space of the outer needle assembly can be suppressed, and the entrainment and retention of air in the sudden volume change portion can be suppressed.
  • the stepped diameter-expanded portion is a portion where the cross-sectional area of the flow path changes abruptly, and includes, for example, a stepped surface extending in the direction perpendicular to the axis.
  • the eighth aspect comprises a flow path forming member connected to a needle, having a valve body inside the flow path forming member, and a first internal space on the tip side of the valve body is based on the valve body.
  • a needle assembly that is longer than the second internal space on the end side, and a ventilation path that allows air in the first internal space to escape to the outside communicates with the first internal space in the vicinity of the valve body.
  • the first internal space is formed at the puncture portion formed in the puncture portion of the needle into the blood vessel and the proximal end side of the puncture portion, and the inner diameter dimension increases toward the proximal end side. It is provided with a tapered portion and a small diameter portion formed on the proximal end side of the tapered portion and having an inner diameter smaller or the same as that of the proximal end of the tapered portion.
  • the outer needle and the inner needle are combined, and the effect of preventing air residue in the lumen of the outer needle assembly having the outer needle is exhibited.
  • the same effect is exhibited in the needle assembly having the needle, and the effect of preventing air residue in the cavity of the needle assembly having the needle is exhibited.
  • this aspect can be understood to be feasible by using the outer needle (48) as the needle of this aspect in the embodiment described later.
  • FIG. 2 is a cross-sectional view showing an outer needle assembly constituting the indwelling needle assembly shown in FIG. 1 in an enlarged manner.
  • FIG. 2 is a cross-sectional view showing an outer needle assembly constituting the indwelling needle assembly shown in FIG.
  • FIG. 1 and 2 show an indwelling needle assembly 12 provided with an outer needle assembly 10 as the first embodiment of the present invention.
  • the indwelling needle assembly 12 has a structure in which the inner needle assembly 14 and the outer needle assembly 10 are combined.
  • the axial direction refers to the left-right direction in FIG. 1, with the left end in FIG. 1 as the tip and the right end in FIG. 1 as the base end.
  • the inner needle assembly 14 includes an inner needle 16.
  • the inner needle 16 is a hollow metal needle, and has a blade surface 18 having an inclined tip surface, whereby a sharp-angled needle tip 20 is formed.
  • the blade surface 18 of the inner needle 16 is provided on the upper side in the drawing.
  • An inner needle hub 22 is provided on the base end side of the inner needle 16.
  • the inner needle hub 22 has a pedestal portion 24 to which the base end portion of the inner needle 16 is fixed in an inserted state, a protector accommodating portion 26 is provided on the tip end side of the pedestal portion 24, and the pedestal portion 24 is provided.
  • a connecting portion 28 is provided on the base end side of the above.
  • the protector accommodating portion 26 has a cylindrical shape. On the tip end side of the protector accommodating portion 26, a regulation cylinder portion 30 having a diameter larger than that of the protector accommodating portion 26 and having a substantially cylindrical shape is provided. The outer peripheral surface of the protector accommodating portion 26 may be provided with anti-slip such as protrusions, recesses, and wrinkles.
  • the connecting portion 28 has a cylindrical shape, and the inner needle cap 32 is detachably inserted and attached.
  • the inner needle cap 32 has a substantially stepped cylindrical shape with a step in the middle portion in the axial direction.
  • a film-like filter 33 having a property of allowing the passage of gas and blocking the passage of liquid is provided at the tip of the inner needle cap 32 so that back blood through the inner needle 16 does not leak to the outside. ing. If the inner needle hub 22 and the inner needle cap 32 are transparent or translucent, it is possible to easily confirm the puncture of the blood vessel by back blood (flashback).
  • a protector housing 34 is arranged on the inner peripheral side of the protector accommodating portion 26.
  • the protector housing 34 includes a tubular accommodating cylinder portion 36 and a lid 38 that closes the opening on the distal end side of the accommodating cylinder portion 36. Further, the lid 38 is provided with a plate-shaped portion on the tip end side and a plate-shaped portion on the base end side separated in the axial direction, and a needle tip protector 40 is arranged between the plate-shaped portions.
  • the needle tip protector 40 is composed of a shielding member 42 and a fixing member 44 housed in the protector housing 34.
  • the shielding member 42 and the fixing member 44 are arranged apart from each other with the inner needle 16 interposed therebetween in the direction perpendicular to the axis.
  • One of the shielding member 42 and the fixing member 44 is a magnet, and the other is a magnet or a ferromagnet, and a magnetic attractive force that attracts each other acts between the shielding member 42 and the fixing member 44. is doing.
  • the shielding member 42 is formed of a ferromagnetic material such as iron
  • the fixing member 44 is a permanent magnet.
  • the fixing member 44 is fixed to the tip end portion of the accommodating cylinder portion 36.
  • the shielding member 42 is displaceable in the approaching direction with respect to the fixing member 44, and when the inner needle 16 is inserted between the shielding member 42 and the fixing member 44, the shielding member 42 moves toward the fixing member 44 of the shielding member 42. The movement of the needle 16 is blocked by the inner needle 16. Then, the inner needle 16 is pulled out from the shielding member 42 to the proximal end side, so that the shielding member 42 is allowed to move to the fixing member 44 side by the magnetic attraction, and the shielding member 42 is the needle of the inner needle 16. It moves to a position that covers the tip 20, and the movement of the inner needle 16 toward the tip end side is blocked by the shielding member 42.
  • the inner needle 16 is inserted through the outer needle assembly 10 in a removable manner.
  • the outer needle assembly 10 is a cylindrical body having a lumen 46 as an internal space penetrating in the axial direction, and is connected to the outer needle 48 in a communicative state with the base end side of the outer needle 48. It has an outer needle hub 50 as a path forming member.
  • the outer needle 48 has a hollow small-diameter tube shape made of synthetic resin or the like.
  • the outer peripheral surface of the outer needle 48 has a tapered shape whose tip gradually becomes smaller in diameter.
  • the base end portion 51 of the outer needle 48 is located on the base end side of the tapered first portion 52 and the first portion 52, which expands in diameter toward the base end and becomes larger in diameter. It has a second portion 54 extending with a substantially constant inner and outer diameter dimension. That is, the outer needle 48 of the present embodiment is a tapered tube with a tapered shape, which is integrally provided with a tapered first portion 52.
  • the base end portion 51 of the outer needle 48 has a diameter larger than that of the tip portion 55 of the outer needle 48 by having the tapered first portion 52.
  • the base end portion 51 of the outer needle 48 in the present embodiment is gradually thickened toward the base end in the first portion 52, and is thicker than the tip end portion 55 of the outer needle 48.
  • the lumen of the outer needle 48 is a puncture portion 56 extending with a substantially constant diameter at the tip portion 55 punctured by a blood vessel, and the first portion of the proximal end portion 51 which is the proximal end side of the puncture portion 56.
  • the tapered portion 57 has an inner diameter that increases toward the proximal end side.
  • the inner peripheral surface of the outer needle 48 is formed of a smoothly continuous curved surface without forming corners such as steps in the axial direction and the circumferential direction.
  • the diameter of the first portion 52 (tapered portion 57) of the tapered shape may be expanded toward the base end as a whole, may be a constant taper angle, or the taper angle may change in the axial direction. May be good.
  • the shape is tapered with respect to the axial length X (see FIG. 3) of the second portion 54 extending substantially straight in the axial direction.
  • the axial length Y (see FIG. 3) of the first portion 52 is relatively long, for example, 1.5X ⁇ Y, and 2X ⁇ Y in the present embodiment.
  • the taper angle ⁇ of the first portion 52 is not limited, the taper angle ⁇ of the first portion 52 is set because the length dimension Y of the first portion 52 of the tapered shape is relatively long. It is set relatively loosely.
  • the taper angle ⁇ of the first portion 52 is an inclination angle with respect to the axial direction of a straight line connecting the base end of the tip portion 55 located on both sides of the first portion 52 and the tip of the second portion 54. As described above, by setting the taper angle ⁇ of the first portion 52 relatively gently, a sudden volume change in the internal space of the outer needle 48 is suppressed.
  • the axial length Y of the first portion 52 is the axial length between the tip portion 55 and the second portion 54 of the outer needle 48 extending with substantially constant inner and outer diameter dimensions.
  • the outer needle hub 50 has a cylindrical shape as a whole, and has a structure in which the needle joining member 58 and the flow path connecting member 59 are connected by a tube 60.
  • the needle joining member 58 is made of a hard synthetic resin.
  • the needle joining member 58 has a tapered cylindrical shape having a smaller diameter toward the tip.
  • a base end portion 51 of the outer needle 48 is inserted into the inner circumference of the needle joining member 58.
  • the flow path connecting member 59 has a tubular structure having a connecting portion connected to an external flow path 104, which will be described later, as a base end, and in the present embodiment, the flow path connecting member 59 has a tubular structure with respect to the tubular valve housing 62. It has a structure in which a valve body 64 and a pusher 66 are housed.
  • the tip portion of the cylindrical pusher guide 70 is inserted into the base end portion of the tubular cover member 68, and the cover member 68 and the pusher guide 70 are axially oriented. It is composed by being concatenated.
  • a tube connecting member 72 is attached to the cover member 68 in an inserted state.
  • the tube connecting member 72 is overlapped and fixed to the inner peripheral surface of the tip portion of the cover member 68.
  • the base end portion of the tube connecting member 72 is arranged to face the cover member 68 at a position distant from the inner circumference.
  • An annular tube fixing portion 73 projecting to the inner peripheral side is provided at the base end portion of the tube connecting member 72.
  • the end surface on the distal end side of the tube fixing portion 73 is an annular flat surface, and the proximal end surface of the tube 60 is in contact with the end surface, and the inner peripheral surface of the tube fixing portion 73 is a tapered surface whose diameter gradually increases toward the proximal end side. It is said to be 73a.
  • a substantially cylindrical base end cylinder portion 73b is provided so as to project toward the base end side with a constant inner diameter size from the portion having the largest inner diameter dimension.
  • the minimum inner diameter dimension C1 (see FIG. 3) on the tapered surface 73a of the tube fixing portion 73 is larger than the inner diameter dimension r1 of the tube 60 described later, and the inner peripheral end portion at the base end of the tube 60 is fixed to the tube. It protrudes toward the inner peripheral side of the inner peripheral end of the portion 73. Further, the minimum inner diameter dimension C1 on the tapered surface 73a is smaller than the outer diameter dimension of the tube 60. Further, the inner diameter dimension C2 (see FIG. 3) of the base end cylinder portion 73b of the tube fixing portion 73 is made larger than the minimum inner diameter dimension C1 of the tapered surface 73a.
  • the tube fixing portion 73 having the tapered surface 73a in the opening portion on the proximal end side of the tube 60 the inner diameter dimension of the first internal space 78, which will be described later, is gradually or gradually adjusted toward the ventilation path 80. It has been made larger.
  • the axial dimension D (see FIG. 3) of the tube fixing portion 73 including the base end cylinder portion 73b is set to be relatively small.
  • the pusher guide 70 has a base end portion extending in the axial direction with a substantially constant cross-sectional shape, and a male screw portion 74 projecting toward the outer circumference is integrally formed at the base end (see FIG. 1).
  • the valve body 64 has a substantially disk shape as a whole, and is formed of an elastic body such as a resin elastomer or rubber.
  • the valve body 64 has a radial notch 76 formed in the central portion of the disk shape, and the notch 76 is opened and closed by elastic deformation of the central portion.
  • the outer peripheral portion of the valve body 64 is axially sandwiched between the tip of the pusher guide 70 and the tubular valve support member 77 arranged on the inner circumference of the cover member 68. As a result, the valve body 64 is supported by the valve housing 62, and the lumen of the valve housing 62 is blocked by the valve body 64.
  • the lumen 46 of the outer needle assembly 10 is divided into a distal end side and a proximal end side with respect to the valve body 64, and the valve body in the lumen 46 is divided.
  • the distal end side of 64 is the first internal space 78
  • the proximal end side of the valve body 64 in the lumen 46 is the second internal space 79.
  • the first internal space 78 is longer than the second internal space 79 in the axial direction.
  • the axial length D of the tube fixing portion 73 that supports the tube 60 from the proximal end side is relatively small, so that the tube 60 has a relatively small axial length D.
  • the proximal end surface and the distal end surface of the valve body 64 face each other relatively close to each other in the axial direction.
  • the tube fixing portion 73 is provided with a proximal cylinder portion 73b protruding toward the proximal end side, and the axially opposed distance between the proximal end tubular portion 73b and the distal end surface of the valve body 64 is the base of the tube 60. It is made smaller than the facing distance between the end surface and the tip surface of the valve body 64.
  • the first internal space 78 of the outer needle assembly 10 is communicated with the ventilation passage 80 through the gap between the base end cylinder portion 73b and the front end surface of the valve body 64.
  • the base end of the tube 60 and the valve body 64 are relatively close to each other, and the valve body 64 easily guides the gas outward in the circumferential direction, making it difficult for bubbles to remain.
  • the valve support member 77 is arranged at a position slightly distant from the cover member 68 to the inner circumference, and a gap is provided between the valve support member 77 and the cover member 68 in the radial direction.
  • the ventilation path 80 that communicates the lumen 46 of the outer needle assembly 10 to the external space is configured to include a gap between the valve support member 77 and the cover member 68.
  • One end of the ventilation passage 80 is communicated with the first internal space 78 of the outer needle assembly 10 through between the tube connecting member 72 and the valve support member 77, and the other end is pushed with the cover member 68. It is communicated to the external space through the child guide 70.
  • the tip side (first internal space 78) of the lumen 46 of the outer needle assembly 10 with respect to the valve body 64 is communicated with the external space through the ventilation passage 80.
  • the air passage 80 has a small cross-sectional area to allow the flow of gas and limit the flow of liquid.
  • the ventilation passage 80 of the present embodiment has a large cross-sectional area in the intermediate portion, and if blood enters the ventilation passage 80, the blood is stored in the intermediate portion and the blood is discharged from the ventilation passage 80 to the outside. It is difficult to leak into the space.
  • the configuration of the ventilation path is not limited to the embodiment of the present embodiment, and may be provided on the outer surface side of the valve body, for example, so that the gas moves to the proximal end side through the outer surface side of the valve body and is discharged to the external space.
  • the ventilation passage 80 is provided on the outer peripheral side of the valve body 64, and the opening on the first internal space 78 side in the ventilation passage 80 is on the outer peripheral side of the tube 60 and the tube fixing portion 73. It is provided. Since the inner diameter of the base end portion of the tube 60 is gradually increased by the tube fixing portion 73, in other words, at the base end portion of the tube 60, a ventilation path is provided from the base end side opening of the tube 60. The inner diameter is increased toward 80.
  • a ventilation filter 82 is arranged in the ventilation passage 80.
  • the ventilation filter 82 is a filter that allows the passage of gas and restricts the passage of liquid such as blood, and is cylindrical or annular.
  • the ventilation filter 82 is arranged between the tube connecting member 72, the valve support member 77, and the cover member 68 in the radial direction, and is held in a compressed state in the radial direction. Since the ventilation filter 82 is arranged on the ventilation passage 80, the infiltration of blood into the ventilation passage 80 is suppressed by the ventilation filter 82 in a state where the lumen 46 of the outer needle assembly 10 is filled with blood. , Leakage of blood to the outside through the ventilation passage 80 is prevented.
  • the pusher 66 has a cylindrical shape and is inserted into the inner circumference of the pusher guide 70.
  • the pusher 66 has a tapered shape in which the base end portion has a substantially constant outer diameter and the outer peripheral surface of the tip portion has a smaller diameter toward the tip end side.
  • the tube 60 connecting the needle joining member 58 and the flow path connecting member 59 is a flexible soft tube made of a resin elastomer, rubber, or the like, and can be curved and deformed, and the cross-sectional shape can be changed. It is allowed.
  • By providing the tube 60 for example, it becomes easy to connect the external flow path 104 to the outer needle hub 50 in a state where the needle joining member 58 is fixed to the skin.
  • the tip portion of the tube 60 is fixed to the needle joining member 58, and the base end portion is inserted and fixed to the inner circumference of the tube connecting member 72 attached to the flow path connecting member 59.
  • the needle joining member 58 and the flow path connecting member 59 are connected by the tube 60, and the lumen of the flow path connecting member 59 is communicated with the lumen of the tube 60.
  • the intermediate portion located between the distal end portion and the proximal end portion of the tube 60 is detached from both the needle joining member 58 and the flow path connecting member 59, and deformation such as bending and crushing is allowed.
  • the base end portion 51 of the outer needle 48 is inserted and connected to the tip end portion of the tube 60.
  • the tip portion of the tube 60 is sandwiched and fixed between the base end portion 51 of the outer needle 48 and the needle joining member 58 in the radial direction, and the outer needle hub 50 including the needle joining member 58 and the tube 60 is fixed. Is connected to the base end side with respect to the outer needle 48.
  • the method of fixing the needle joining member 58, the base end portion 51 of the outer needle 48, and the tip end portion of the tube 60 is not limited, but for example, the base end of the outer needle 48 is attached to the large diameter tubular portion 84 of the tube 60.
  • the portion 51 is inserted in a press-fitted state and adhered as needed.
  • the protrusion on the inner surface of the needle joining member 58 may be used to position the insertion end of the tube 60 into the needle joining member 58 and to hold the large diameter tubular portion 84 under pressure.
  • the lumen of the outer needle 48 and the lumen of the outer needle hub 50 are communicated with each other, and the lumen 46 of the outer needle assembly 10 is the lumen of the outer needle 48 and the lumen of the outer needle hub 50. Is configured to include.
  • the tube 60 is a large-diameter tubular portion 84 whose inner diameter is larger than the portion where the tip portion fixed to the outer needle 48 is located away from the outer needle 48 toward the proximal end side. Since the outer diameter of the tube 60 is substantially constant in the axial direction, the tube 60 is thin in the large diameter tube portion 84.
  • the tube 60 includes an annular stepped surface 86 that connects the inner peripheral surface of the large-diameter tubular portion 84 and the inner peripheral surface of the portion of the large-diameter tubular portion 84 that is detached from the base end side.
  • the step surface 86 is provided on the inner peripheral portion of the tube 60 and extends in the direction perpendicular to the axis.
  • the tube 60 has a substantially constant inner diameter dimension r1 (described later) on the proximal end side of the stepped surface 86.
  • the outer needle 48 has a second portion 54 constituting the base end portion 51 inserted into the inner circumference of the large diameter tubular portion 84 and is fixed to the tube 60 in an inserted state.
  • the large-diameter tubular portion 84 which is the tip end portion of the tube 60, is held in a state of being radially sandwiched by the second portion 54 of the outer needle 48 and the needle joining member 58.
  • the outer peripheral surface of the second portion 54 of the outer needle 48 is overlapped with the inner peripheral surface of the large diameter tubular portion 84 of the tube 60 in an abutting state.
  • the base end surface of the outer needle 48 is abutted against the stepped surface 86 of the tube 60 in the axial direction, so that the outer needle 48 and the tube 60 are mutually positioned in the axial direction. That is, in the present embodiment, the outer needle 48 and the tube 60 are in direct contact with each other.
  • the inner circumference of the outer needle 48 is not provided with an outer needle fixing member for pressing the outer needle 48 against the large-diameter cylinder portion 84 to fix the outer needle 48, and the outer needle fixing member is provided on the inner circumference of the outer needle 48. Since the formation of a step is avoided by arranging the step, the entrainment of air in the blood due to the step is prevented.
  • the taper angle ⁇ of the tapered portion 57 of the outer needle 48 is set to be relatively gentle, it is possible to prevent air from being entrained or staying due to a sudden volume change in the internal space of the outer needle 48. It is also possible. In particular, when the taper angle ⁇ is set to 30 degrees or more or 45 degrees or more, a substantially stepped shape is formed, and there is a concern that air may be caught or stagnated.
  • the inner diameter dimension r1 of the tube 60 is set to be equal to or less than the inner diameter dimension r2 of the outer needle 48 (r1 ⁇ r2). In other words, it is the size obtained by dividing the difference obtained by subtracting the inner diameter dimension r1 of the tube 60 at the connection portion 88 between the outer needle 48 and the tube 60 from the inner diameter dimension r3 of the base end of the large diameter tubular portion 84 in the tube 60, divided by 2.
  • the inner diameter dimension r1 of the tube 60 is reduced to a range that can be regarded as substantially the same as the inner diameter dimension r2 of the base end of the outer needle 48. ing.
  • the inner diameter r1 of the tube 60 is preferably 2.6 mm or less, and more preferably the inner diameter r1 of the tube 60 is 2.5 mm or less.
  • the inner diameter dimension r2 of the outer needle 48 is 2.5 mm ⁇ r2 ⁇ 3.3 mm. More preferably, the inner diameter r2 of the outer needle 48 is set to, for example, 2.9 mm, which is larger than the inner diameter r1 of the tube 60.
  • the inner diameter of the tube 60 is substantially constant from the connection portion 88 of the outer needle 48 and the tube 60 to the base end of the tube 60, and the inner diameter of the outer needle hub 50 is the connection between the outer needle 48 and the tube 60. From the portion 88 to the base end of the tube 60, the inner diameter dimension r2 or less of the base end of the outer needle 48 is set.
  • the inner diameter dimension A (see FIG. 3) of the tip portion 55 (puncture portion 56) of the outer needle 48 is equal to or less than the inner diameter dimension of the tapered portion 57 of the outer needle 48, and the inner diameter dimension r1 of the tube 60.
  • the inner diameter of the base end of the outer needle 48 is made smaller than r2 (A ⁇ r1 ⁇ r2).
  • the inner diameter A of the puncture portion 56 in the outer needle 48 depends on the thickness of the inner needle 16 inserted into the outer needle 48, for example, (inner diameter r1 of the tube 60) ⁇ (1.5 ⁇ A). ). As a result, the change in the cross-sectional area of the internal space of the outer needle 48 can be reduced, and it is possible to make it difficult for bubbles to be involved. Further, it is preferable that (6 ⁇ A) ⁇ (the axial length Y of the tapered portion 57). As a result, the axial length Y of the tapered portion 57 can be secured sufficiently large, so that the tapered portion 57 can be formed into a shape in which the diameter is gradually expanded, and the residual air bubbles can be suppressed.
  • the inner diameter dimension r1 of the tube 60 is, for example, (inner diameter dimension C2 of the base end cylinder portion 73b) ⁇ (2 ⁇ r1). Further, it is preferable that the inner diameter dimension r1 of the tube 60 is, for example, (the axial length E between the valve body 64 and the tube 60) ⁇ (2 ⁇ r1). As a result, the valve body 64 and the tube 60 can be arranged so as to be close to each other. In the present embodiment, (the axial length E between the valve body 64 and the tube 60) is made smaller than the inner diameter dimension r1 of the tube 60.
  • the inner diameter dimension r1 of the tube 60 is, for example, (the axial length D of the tube fixing portion 73) ⁇ r1. Also with this, it is possible to arrange the valve body 64 and the tube 60 in a relatively close state. In the first internal space 78, a ventilation passage 80 is opened in front of the valve body 64. Further, since the inner diameter dimension r1 of the tube 60 and the inner diameter dimension r2 of the base end of the outer needle 48 can be regarded as substantially the same, the same relationship as described above has with respect to the inner diameter dimension r2 of the base end of the outer needle 48. Is considered to be.
  • the inner diameter dimension r2 of the base end of the outer needle 48 is (inner diameter dimension r2 of the base end of the outer needle 48) ⁇ (1.5 ⁇ A). Further, it is preferable that the inner diameter dimension r2 of the base end of the outer needle 48 is, for example, (inner diameter dimension C2 of the base end cylinder portion 73b) ⁇ (2 ⁇ r2). Furthermore, it is preferable that the inner diameter dimension r2 of the base end of the outer needle 48 is, for example, (the axial length E between the valve body 64 and the tube 60) ⁇ (2 ⁇ r2). Further, it is preferable that the inner diameter dimension r2 of the base end of the outer needle 48 is, for example, (the axial length D of the tube fixing portion 73) ⁇ r2.
  • connection portion 88 between the outer needle 48 and the tube 60 is a portion that becomes a boundary between the outer needle 48 and the tube 60 on the inner surface of the inner flow path of the outer needle assembly 10.
  • the connecting portion 88 between the outer needle 48 and the tube 60 in the present embodiment is provided at a portion where the base end surface of the outer needle 48 and the stepped surface 86 of the tube 60 are located in the axial direction.
  • the connecting portion 88 of the outer needle 48 and the tube 60 may include a portion of the tube 60 adjacent to the proximal end side with respect to the large diameter tubular portion 84.
  • connection portion 88 with the tube 60 should also be grasped for the inner surface (inner peripheral surface) of the internal flow path.
  • the proximal end side of the large-diameter tubular portion 84 in the lumen of the tube 60 is provided on the proximal end side of the tapered portion 57 of the outer needle 48 and has a smaller diameter than the proximal end of the tapered portion 57.
  • the small diameter portion is 89.
  • the small diameter portion 89 is axially continuous from the connection portion 88 of the outer needle 48 and the tube 60 to the base end of the tube 60.
  • the small diameter portion 89 extends with a substantially constant diameter dimension, and the inner peripheral surface of the tube 60 has a cylindrical shape at a portion constituting the small diameter portion 89.
  • the small diameter portion 89 has a longer axial length than the tapered portion 57 of the outer needle 48.
  • the first internal space 78 in the lumen 46 of the outer needle assembly 10 on the distal end side of the valve body 64 includes the puncture portion 56 and the tapered portion 57 constituting the lumen of the outer needle 48, and the lumen of the tube 60. It includes a small diameter portion 89 constituting the above.
  • the inner needle 16 is inserted from the proximal end side into the lumen 46 of the outer needle assembly 10 including the lumen of the outer needle 48 and the lumen of the outer needle hub 50. As shown in FIGS. 1 and 2, the inner needle 16 spreads the notch 76 of the valve body 64 arranged in the lumen 46 of the outer needle assembly 10 and penetrates the notch 76.
  • the inner needle assembly 14 provided with the inner needle 16 and the outer needle assembly 10 provided with the outer needle 48 are connected by a connector cap 90.
  • the connector cap 90 includes a bottom wall portion 92 extending in a direction perpendicular to the axis.
  • the bottom wall portion 92 has an annular plate shape, and a tubular protrusion 94 projecting toward the tip side is integrally formed at the inner peripheral end portion.
  • a peripheral wall portion 96 extending toward the tip end side and a pair of elastic pieces 98, 98 extending toward the base end side are integrally formed.
  • a female screw 100 is provided on the inner peripheral surface of the cylindrical wall portion 96. Then, the base end portion of the pusher guide 70 constituting the outer needle hub 50 is inserted into the inner circumference of the peripheral wall portion 96, and the male screw portion 74 of the pusher guide 70 and the female screw 100 of the peripheral wall portion 96 are screwed. By fitting, the connector cap 90 is attached to the base end portion of the outer needle hub 50.
  • the regulation cylinder portion 30 of the inner needle hub 22 is extrapolated to the connector cap 90.
  • the deformation of the elastic pieces 98, 98 to the outer peripheral side is restricted by the restricting cylinder portion 30, and the connection between the connector cap 90 and the protector housing 34 by the pair of locking projections 102, 102 is stably maintained. ..
  • the indwelling needle assembly 12 having such a structure is punctured by the inner needle 16 into a blood vessel such as a patient's arm (not shown).
  • a medical worker (user) who punctures a blood vessel holds the inner needle hub 22 with his / her fingers and punctures the inner needle 16 into a patient's arm or the like.
  • the inner needle 16 and the outer needle 48 are punctured into the patient's blood vessel, the inner needle 16 is removed from the outer needle 48, so that the outer needle assembly 10 is inserted into the patient's blood vessel. Detained.
  • the lumen 46 of the outer needle assembly 10 is filled with air before the inner needle 16 and the outer needle 48 are punctured. Then, when the inner needle 16 is removed from the outer needle 48, blood flows into the lumen 46 of the outer needle assembly 10 from the tip opening of the outer needle 48.
  • the inner diameter dimension r1 of the tube 60 is relative to the inner diameter dimension r2 of the base end of the outer needle 48. Same or smaller. Therefore, the inner surface of the wall of the lumen 46 of the outer needle assembly 10 is not provided with a stepped diameter-expanded portion at the connecting portion 88 of the outer needle 48 and the tube 60.
  • the inner diameter r1 of the tube 60 is smaller than the inner diameter r2 of the base end of the outer needle 48 because air bubbles are less likely to remain.
  • the outer needle assembly 10 When the outer needle is punctured into a blood vessel and the tip of the outer needle assembly is tilted above the proximal end, the connection between the outer needle and the tube in the lumen of the outer needle assembly.
  • the enlarged diameter portion having a large diameter on the base end side is provided in a stepped shape, it is difficult for blood to flow into the enlarged diameter portion and air tends to remain.
  • the outer needle assembly 10 there is no stepped diameter-expanded portion in the lumen 46 of the outer needle assembly 10 in the connection portion 88 of the outer needle 48 and the tube 60, and air is efficiently supplied by blood.
  • the tip of at least one outer needle assembly is on the upper side. Can be oriented.
  • a stepped enlarged diameter portion is not formed on the inner surface of the wall of the lumen 46 of the outer needle assembly 10, so that turbulence is generated due to a rapid expansion of the cross-sectional area. Is reduced. Therefore, the entrainment of air due to turbulence is reduced, and the residual air is suppressed in the lumen 46 of the outer needle assembly 10.
  • a stepped diameter-expanded portion or a portion where the taper angle suddenly increases is provided on the inner peripheral surface of the outer needle assembly 10.
  • the lumen 46 of the outer needle assembly 10 of the present embodiment is not provided with a stepped diameter-expanded portion that exceeds the wall thickness of the outer needle.
  • the base end portion 51 of the outer needle 48 includes a first portion 52 having a gently tapered inner peripheral surface, and the inner diameter of the base end portion 51 increases toward the base end.
  • connection portion 88 between the outer needle 48 and the tube 60 is a portion where the base end portion 51 of the outer needle 48 is tapered in diameter and the flow velocity suddenly decreases, and in addition, a stepped diameter expansion portion is likely to occur. Since it is a location, in addition to the fact that blood is likely to be divided by air in the flow path, it is located away from the air passage 80 toward the tip side. Therefore, if air remains or is entrained in the connection portion 88 of the outer needle 48 and the tube 60 due to the diameter expansion, the remaining air does not easily reach the ventilation passage 80 and tends to remain in the lumen 46 of the outer needle assembly 10.
  • the lumen 46 of the outer needle assembly 10 of the present embodiment has a stepped diameter at the base end of the tube 60, but the enlarged diameter portion has a tapered diameter of the outer needle 48.
  • the ventilation path 80 is provided on the outer peripheral side of the tube 60, and the lumen 46 of the outer needle assembly 10 is ventilated by increasing the diameter stepwise or gradually at the base end of the tube 60. It spreads in the direction toward the road 80.
  • the inner diameter dimension of the small diameter portion 89 formed on the proximal end side of the tapered portion 57 is smaller than the inner diameter dimension of the proximal end of the tapered portion 57.
  • the ventilation passage 80 that opens in the vicinity of the valve body 64 on the proximal end side of the small diameter portion 89 is not blocked by the preceding blood, and air is effectively discharged through the ventilation passage 80, and the first interior is provided. Residue of air at the time of blood introduction is prevented in the space 78.
  • the connector cap 90 is removed from the outer needle hub 50, and as shown in FIG. 4, the male connector 106 constituting the outer flow path 104 is the outer needle. It is inserted into the pusher guide 70 of the hub 50 from the base end side. Further, a lock portion (not shown) provided on the male connector 106 constituting the external flow path 104 is screwed to the male screw portion 74 provided on the flow path connecting member 59 of the outer needle hub 50. As a result, the outer needle assembly 10 and the outer flow path 104 are connected, and the lumen 46 of the outer needle assembly 10 is communicated with the outer flow path 104.
  • the male screw portion 74 of the outer needle hub 50 is used for both the connection of the connector cap 90 to the outer needle hub 50 and the connection of the outer flow path 104 to the outer needle hub 50.
  • the male connector 106 does not have to have a lock portion (not shown), and the male connector 106 may be fitted to the base end of the pusher guide 70 so that the male connector 106 and the pusher guide 70 are connected to each other. can.
  • the pusher 66 When the male connector 106 is connected to the outer needle hub 50, the pusher 66 is pushed toward the tip side by the male connector 106. The pushed element 66 is pressed against the valve body 64 to deform the valve body 64, so that the notch 76 of the valve body 64 is opened. As a result, the patient's blood vessel and the external flow path 104 are connected to each other through the lumen 46 of the outer needle assembly 10, and treatment such as hemodialysis, blood collection, and administration of a drug solution can be performed.
  • valve body 64 In a state where the external flow path 104 shown in FIG. 4 is connected to the outer needle assembly 10, the valve body 64 pushed open by the pusher 66 covers the opening on the lumen 46 side of the ventilation path 80, and is ventilated. The road 80 is blocked by the valve body 64. As a result, the valve body 64 prevents the leakage of blood, chemicals, and the like through the ventilation passage 80 to the outside. However, blocking the air passage 80 by the valve body 64 is not essential.
  • FIG. 5 shows an outer needle assembly 110 as a second embodiment of the present invention.
  • the outer needle assembly 110 includes a tube 112.
  • the members and parts substantially the same as those in the first embodiment are designated by the same reference numerals in the drawings, and the description thereof will be omitted.
  • the tube 112 has a structure in which the small diameter cylinder portion 114 is continuously provided on the base end side of the large diameter cylinder portion 84 constituting the tip portion.
  • the small diameter cylinder portion 114 has a substantially cylindrical shape, and the inner diameter dimension and the outer diameter dimension are substantially constant in the axial direction. Both the inner diameter dimension and the outer diameter dimension of the small diameter cylinder portion 114 are smaller than those of the large diameter cylinder portion 84.
  • the small-diameter cylinder portion 114 of the present embodiment has substantially the same thickness as the large-diameter cylinder portion 84, but the small-diameter cylinder portion 114 may be thicker or thinner than the large-diameter cylinder portion 84. There may be.
  • a thick-walled connecting portion 116 is provided on the base end side of the small-diameter tubular portion 114.
  • the thick-walled connecting portion 116 has an outer diameter dimension that is substantially the same as that of the large-diameter tubular portion 84, and an inner diameter dimension that is substantially the same as that of the small-diameter tubular portion 114. It is said to be thick.
  • the outer diameter of the tube 112 is smaller in the small diameter tubular portion 114, which is an intermediate portion in the axial direction, than in the large diameter tubular portion 84 and the thick-walled connecting portion 116, which are both end portions.
  • the tube 112 side has a large diameter in the connection portion 88 between the outer needle 48 and the tube 112, as in the first embodiment. However, when blood flows in, air is prevented from remaining in the lumen 46 of the outer needle assembly 110.
  • the tube 112 has a smaller diameter than the large diameter cylinder portion 84 fixed to the outer needle 48 in the small diameter cylinder portion 114 provided on the proximal end side of the portion fixed to the outer needle 48. Therefore, in the small diameter cylinder portion 114, the forming material can be saved by making the small diameter cylinder portion 114 thinner while keeping the inner diameter dimension of the tube 112 equal to or less than the inner diameter dimension of the base end of the outer needle 48.
  • the tube 112 is made thin in the small diameter cylinder portion 114, the elasticity of the small diameter cylinder portion 114 can be reduced so that the small diameter cylinder portion 114 can be easily deformed. Therefore, it is possible to facilitate the connection between the outer needle hub 50 and the external flow path (not shown) by bending the tube 112.
  • FIG. 6 shows an outer needle assembly 120 as a third embodiment of the present invention.
  • the outer needle hub 122 as a flow path forming member in the present embodiment includes a branch member 126 having a branch portion 124, and in such a branch portion 124, a main flow path extending from the outer needle 48 to the proximal end side is laterally provided. It is branched to form a branch port portion 132 having a branch flow path.
  • FIG. 6 shows a state in which the inner needle (16) is pulled out in the same manner as in FIGS. 3 and 5.
  • the connection portion between the base end side of the outer needle 48 and the outer needle hub 122 is shown in FIG. 3 in the first embodiment. Since it is substantially the same as the structure, the illustration of the internal structure is omitted. That is, in the present embodiment, the internal structure at the connection portion between the base end portion of the outer needle 48 and the outer needle hub 122 is such that the tube 60 in the first embodiment is replaced with the branch member 126. ..
  • the tip portion of the branch member 126 is provided with a large-diameter tubular portion (corresponding to the large-diameter tubular portion 84 in FIG. 3) having a large inner diameter, and the branch member 126 has a large diameter.
  • the base end portion (51) of the outer needle 48 is inserted into the diameter cylinder portion and is fixed to the branch member 126 (corresponding to the tube 60 in FIG. 3) in an inserted state.
  • the inner diameter of the branch member 126 (corresponding to the inner diameter r1 of the tube 60 in the first embodiment) is the same as or smaller than the inner diameter r2 of the base end of the outer needle 48, so that the outer needle 48 A small diameter portion (89) is provided at the connection portion between the base end side of the surface and the outer needle hub 122.
  • the connection portion of the external flow path (104) on the proximal end side of the outer needle hub 122 is shown in FIGS. 3 and 4 in the first embodiment. Since it is substantially the same as the structure, the illustration and description of the internal structure will be omitted. Further, in the present embodiment, since the branch port portion 132 provided at the base end of the branch flow path is substantially the same as the connection port portion 134 provided at the base end of the main flow path, the internal structure is shown. And the explanation is omitted.
  • the flow path connecting member 59 is connected to each of the main flow path and the branch flow path via the tube 112.
  • the tube 112 has a small diameter tubular portion 114 as in the second embodiment.
  • the tip of the tube 112 is fitted and fixed to the lumen 46 (main flow path) of the branch member 126.
  • the inner diameter of the tube 112 is an enlarged diameter-expanded portion on the tip side, and the tip opening diameter of the enlarged diameter portion is smaller than the inner diameter of the main flow path in the branch member 126. ..
  • the connecting portion between the main flow path and the tube 112 in the branch member 126 has a substantially stepped small diameter from the tip end side to the base end side.
  • the base end side of the enlarged diameter portion has a small diameter in a substantially stepped shape toward the flow path connecting member 59 side.
  • the outer needle assembly 120 of the present embodiment also has a small diameter portion (89) located at the connection portion (88) on the proximal end side of the outer needle 48 and having a substantially stepped shape as in the first embodiment. Therefore, the above-mentioned effect of the present invention can be achieved without providing a stepped small diameter portion on the base end side of the branch member 126. Therefore, the flow path on the proximal end side of the branch member 126 may have a substantially constant inner diameter, and may be separated from the tapered proximal end portion 51 of the outer needle 48 and into the air passage 80. Since they are close to each other, even if the diameter of the flow path expands from the tip end side to the base end side, the problem of air entrainment or residue in the flow liquid is unlikely to occur.
  • a valve body and a ventilation path may be provided inside the base end connector of the indwelling needle as in JP-A-2004-298622 and JP-A-2014-108112, and the configuration of the present invention may be adopted.
  • the inner circumference of the tube 60 is set. Even when the radial width dimension of the stepped surface 86 provided on the surface is smaller than the thickness dimension of the base end of the outer needle 48, the stepped diameter expansion at the connecting portion 88 of the outer needle 48 and the tube 60 is avoided. ..
  • the outer needle 48 may be connected to the tube 60 in an extrapolated state.
  • the outer diameter of the tip portion of the tube 60 may be reduced to make it thinner, or the inner diameter of the base end portion 51 of the outer needle 48 may be made larger to make it thinner. It is desirable to reduce the step formed in the connection portion 88 of the tube 60.
  • the outer needle 48 may be abutted against the tube 60 in the axial direction and connected by means such as welding.
  • the tube 60 does not have to have a constant thickness dimension, for example, between the needle joining member 58 and the flow path connecting member 59, for example, the inner peripheral surface gradually protrudes inward toward the center in the axial direction. It may be thick.
  • the outer peripheral surface of the portion of the inner needle 16 to be inserted into the tube 60 is the inner peripheral surface of the tube 60 due to, for example, roughening of unevenness, grain, etc., or coating with elastomer, rubber, synthetic resin, etc. having a large frictional resistance.
  • a non-slip anti-slip can be provided. By doing so, when the tube 60 is gripped, slippage between the tube 60 and the inner needle 16 is less likely to occur, and the relative positions of the inner needle 16 and the outer needle 48 are less likely to be displaced.
  • the structure (non-slip) that makes it difficult to slip on the inner peripheral surface of the tube 60 may not be provided on the outer peripheral surface of the inner needle 16, and may be provided on the inner peripheral surface of the tube 60, for example. .. In short, the non-slip is provided between the inner needle 16 and the tube 60, in other words, at least one of the outer peripheral surface of the inner needle 16 and the inner peripheral surface of the tube 60.
  • a flexible tube is not essential in the flow path forming member, and for example, the structure may be such that the valve body is housed in the flow path forming member which is made entirely rigid. Specifically, for example, a structure in which the needle joining member and the flow path connecting member are directly fixed without using a tube can be adopted.
  • the ventilation passage 80 is provided with a ventilation filter 82 for preventing blood leakage, but for example, blood leakage is prevented by the cross-sectional area and cross-sectional shape of the ventilation passage.
  • a ventilation filter it is not necessary to provide a ventilation filter.
  • the ventilation path is not limited to a structure extending between the components of the flow path forming member, and may be, for example, a hole structure penetrating the components of the flow path forming member.
  • Outer needle assembly (first embodiment) 12 Indwelling needle assembly 14 Inner needle assembly 16 Inner needle 18 Blade surface 20 Needle tip 22 Inner needle hub 24 Pedestal 26 Protector housing 28 Connecting part 30 Restricting cylinder 32 Inner needle cap 33 Membrane filter 34 Protector housing 36 Cylinder 38 Lid 40 Needle tip protector 42 Shielding member 44 Fixing member 46 Lumen (internal space) 48 Outer needle 50 Outer needle hub (flow path forming member) 51 Base end part 52 First part 54 Second part 55 Tip part 56 Puncture part 57 Tapered part 58 Needle joining member 59 Flow path connecting member 60 Tube 62 Valve housing 64 Valve body 66 Pusher 68 Cover member 70 Pusher guide 72 Tube Connecting member 73 Tube fixing part 73a Tapered surface 73b Base end tube part 74 Male thread part 76 Notch 77 Valve support member 78 First internal space 79 Second internal space 80 Ventilation path 82 Ventilation filter 84 Large diameter tube part 86 Step surface 88 Connection part 89 Small diameter 90 Connector cap 92 Bottom

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Pulmonology (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Biophysics (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
PCT/JP2021/023686 2020-06-22 2021-06-22 外針組立体 WO2021261500A1 (ja)

Priority Applications (6)

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CN202180044117.8A CN115835899A (zh) 2020-06-22 2021-06-22 外针组装体
US18/011,975 US20230256206A1 (en) 2020-06-22 2021-06-22 Outer needle assembly
EP21829750.5A EP4169551A1 (en) 2020-06-22 2021-06-22 Outer needle assembly
JP2022532505A JPWO2021261500A1 (zh) 2020-06-22 2021-06-22
AU2021297440A AU2021297440A1 (en) 2020-06-22 2021-06-22 Outer needle assembly
CA3187022A CA3187022A1 (en) 2020-06-22 2021-06-22 Outer needle assembly

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JP2020-106775 2020-06-22

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EP (1) EP4169551A1 (zh)
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AU (1) AU2021297440A1 (zh)
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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2004298622A (ja) 2003-03-20 2004-10-28 Nipro Corp 翼付針用プロテクター
JP2014108112A (ja) 2012-11-30 2014-06-12 Nipro Corp 留置針組立体
JP2015080707A (ja) 2013-10-24 2015-04-27 株式会社トップ 留置針
WO2019146791A1 (ja) * 2018-01-26 2019-08-01 ニプロ株式会社 ハブ組立体

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2004298622A (ja) 2003-03-20 2004-10-28 Nipro Corp 翼付針用プロテクター
JP2014108112A (ja) 2012-11-30 2014-06-12 Nipro Corp 留置針組立体
JP2015080707A (ja) 2013-10-24 2015-04-27 株式会社トップ 留置針
WO2019146791A1 (ja) * 2018-01-26 2019-08-01 ニプロ株式会社 ハブ組立体

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AU2021297440A1 (en) 2023-02-02
CN115835899A (zh) 2023-03-21
US20230256206A1 (en) 2023-08-17
EP4169551A1 (en) 2023-04-26
JPWO2021261500A1 (zh) 2021-12-30

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